Zoloft (Lustral) neurobiological interest item kept from GP's eyes ....by Pfizer

[Guest guest]

Trouble in Prozac Nation

http://www.fortune.com/fortune/investing/articles/0,15114,1130139-

8,00.html

Wonder drugs of the 1990s, Prozac and its kin have been prescribed

to tens of millions of people. But a growing backlash may portend

the end of an era.

By Stipp

(Photo: Phil Toledano)

An internal Pfizer memo on the akathisia report may backfire on the

company. Obtained by Witczak's attorneys in pretrial

proceedings, it makes the remarkable statement, " This article is not

suited for distribution to general practitioners, but may be of

interest to neurobiologically inclined psychiatrists. " Was Pfizer

leery of scaring GPs away from Zoloft? Responds company spokesman

Haskins: " It's a bit absurd to allege that Pfizer thought the

paper revealed some serious health issue and [then] decided to keep

the information hidden by publishing it in a medical journal. " He

adds that the paper " makes crystal-clear that the scientific basis

for any causal connection between SSRIs and akathisia is very weak. "

The SSRI backlash is being fueled by people across the political

spectrum. Dr. Sidney Wolfe of the liberal watchdog group Public

Citizen in Washington, D.C., for example, has long argued that the

drugs are overprescribed; conservative activists such as Phyllis

Schlafly have launched campaigns against prescribing SSRIs and other

psychiatric drugs to children based on mental-health screening

programs.

How the controversy will affect Big Pharma revenues and profits

isn't clear, though. Since generic SSRIs are now on the market

(Prozac's U.S. patent expired in 2001), drugmakers are racing to

bring out new versions of antidepressants. Concerns about SSRIs may

help speed the transition to such pricier, patent-protected

alternatives, offsetting the controversy's fiscal fallout. Or the

new drugs could themselves be damaged by the skepticism that has

besieged the industry.

The FDA's scrutiny certainly seems to have intensified. Last year

Lilly launched a successor to Prozac called Cymbalta. It's an SNRI,

a class of drugs that has been hailed as offering significant

advantages over SSRIs, such as faster action. (SNRIs are touted as

targeting two different chemical messengers in the brain instead of

just serotonin, as SSRIs do.) A few months later Lilly dropped plans

to seek approval for the drug as a treatment for urinary

incontinence in women. Last July the FDA revealed in a public alert

that " a higher than expected rate of suicide attempts was observed "

in clinical trials with incontinence patients on Cymbalta. Increased

suicide risks hadn't been seen in earlier trials of the drug. (A

Lilly spokesman says that the Cymbalta suicide-attempt rate, while

higher than the rate for the U.S. population, is " consistent " with

worldwide suicide rates.) Such problems may someday be resolved by

genetic testing. It could take the guesswork out of determining

which patients a drug might help and which it might hurt.

Waiting for her day in court, Kim Witczak appeared at another

Washington, D.C., forum this month—an FDA public hearing on direct-

to-consumer drug ads. " Prescription drugs ... should not be treated

in the same manner as cars, soap, or fast food, " she told agency

officials. Safety has to be No. 1, she added, and all serious side

effects ought to be communicated " in a clear, concise, and honest

manner, not just those that won't scare people away from thinking

twice about taking the drug. "

Witczak's comments sounded like points her attorney is likely to

make to a jury. But as a success formula for the post-Prozac era,

transparency might be just the prescription that pharmaceutical

marketers need.

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